Abstract

A new U.S. policy for dual-use life science research defines what is permissible by scientists and the government. However, further negotiations will be needed as governments realize the consequences of such boundaries for research and society.

The recent furor surrounding H5N1 influenza research and the intervention of national and international governmental bodies into the publication process (1) have brought to the fore a long-standing question regarding the relationship between science and society. That is, what is the proper role of government in regulating science? The science-society relationship has evolved from a time when science was seen as best left to the scientists to the current environment in which scientists are subject to competing claims from an expanding number of stakeholders who see the relevance of science to their core concerns—businesses seeking a profit, universities seeking federal and state funding, patients seeking cures, and politicians seeking votes, among others. As such, there has been an increasing demand for accountability on the part of the scientific community. Toward this end, what should governments do?

The responsibilities associated with being a scientist can be viewed as two basic types. One is internal to science, which addresses the responsibility to adhere to accepted standards of scientific practice when conducting and reporting research. The other goes beyond the responsibilities related to doing science, focusing more on the social consequences of applying research findings. The H5N1 case, in which two research papers (2–4) show that the virus can mutate into a form that might spread rapidly among humans, presents a very compelling challenge for scientists. The controversy over whether to publish the papers intersects with both types of responsibilities. For the first type, it raises questions about how much of a researcher’s methods should be readily accessible for others to assess the integrity of the research and its relationship to the published findings, which go to the core of what the scientific community considers to be acceptable research practices. It also raises questions about the scope of scientists’ social responsibilities when the research has dual-use implications—offering knowledge that could contribute to greater resilience in the face of a potential pandemic, as well as be intentionally misused or accidentally released with potentially catastrophic effects. The H5N1 case also illuminates scientists’ responsibility to follow appropriate biosafety practices to safeguard fellow researchers, as well as the public. World-leading H5N1 researchers agreed to a voluntary, temporary moratorium on research to allow for international discussion (5).

For governments, the challenges of responding to the H5N1 controversy are also compelling. They must deal with increasing public calls for greater government oversight of research, while at the same time relying on scientists to help them prepare for a pandemic disaster. They must also avoid overregulation out of concern that their actions will impede discoveries and innovation. Determining the level of regulation that is “just right” is a balancing act among many competing interests. What the history of the science-society relationship reveals is that the result is an outcome of ongoing negotiations by a range of stakeholders to determine the authority, jurisdiction, and responsibilities—setting the boundaries—of what is or is not permissible action by scientists and the government (6).

The debate over the two research papers led to a resolution regarding their publication (7) in which one paper was published in May by Nature (3) while the other is published in this issue of Science (4), both in updated, uncensored forms. However, that does not end the negotiations. At a recent hearing before the United States Senate, called primarily in response to the H5N1 research, Senator Joseph Lieberman (I-CT) remarked that “Although this particular issue appears to have been resolved, it’s going to recur and we can’t just ‘kick this can down the road’ and deal with it on an ad hoc basis when it happens again” (8). This is a reminder that while the focus of attention has been on the two papers, there is a larger landscape for which boundaries have yet to be negotiated.

One attempt to draw those boundaries in the United States is the new U.S. Policy for Oversight of Life Sciences Dual Use Research of Concern, designed “to establish regular review of United States Government funded or conducted research with certain high-consequence pathogens and toxins for its potential to be dual use research of concern (DURC)” (9). The Policy lists as a principle that the “Government will facilitate the sharing of the results and products of life sciences research conducted or funded by United States Government agencies,…. In executing this Policy, the United States Government will abide by and enforce all relevant Presidential Directives and Executive Orders,…." (9). On the surface, that’s good news for science, since current U.S. policy for “sharing of the results and products” of research relative to national security is governed by a Presidential National Security Decision Directive (NSDD-189) issued in 1985 that fundamental (i.e.,“basic”) research will remain “unrestricted,” or if national security concerns require control, the mechanism for doing so will be to classify the research (10). However, if one reads further in the new U.S. Policy, the boundaries are less clear. The Policy gives the federal government the responsibility to consider “risk mitigation measures,” including the following: “Determining the venue and mode of communication (addressing content, timing, and possibly the extent of distribution of the information) to communicate the research responsibly.” If such measures are not adequate, the government will determine whether to “classify the research” or “Not provide or terminate research funding.” The possibility of having one’s research classified or funding terminated after the research is underway is not conducive to good science and may well discourage some researchers from engaging in such work.

The U.S. government’s policy is a boundary-changing document in its relationship with U.S.-based researchers engaged in dual-use life sciences research, setting aside a previous approach that had essentially deferred to the research community (i.e., scientists, their institutions, and journal editors) to decide what, how, and when research is published. But what does this mean for international research?

The Policy does apply to U.S. scientists in research partnerships with non-U.S. scientists, which could put those collaborations under a cloud of considerable uncertainty, if not in jeopardy. It could also put U.S. science at a disadvantage in competing for international prominence. The Policy does acknowledge the need to pursue “engagement with our international partners” but offers no details. There will be much boundary negotiation, as governments jockey over how policy differences, where policies exist at all, will be reconciled. One troubling example from the H5N1 incident is that the Netherlands required the authors of one of the disputed papers (4) to apply for government permission to submit their paper for publication, claiming that the study falls “under regulations that control the export of weapons technology” (11). That view of the research would appear to be in conflict with the U.S. NSDD-189, as well as U.S. export control regulations, which exempt basic research. But, then, boundaries are often fuzzy and subject to interpretation, and which ones will prevail is often unpredictable. In this case, the Netherlands government viewed the H5N1 research as applied, not basic, and although the authors contested this view, they applied (and received) an export license (12).

What dual-use life sciences research will look like in the U.S. and whether, how, and when it might be disseminated are still open to boundary definition. Toward that end, governments should agree on a core set of principles that reflect a global consensus on fostering international cooperation, followed by efforts to harmonize policies and practices, including those pertaining to the dissemination of dual-use research, to mitigate the potential for malevolent uses of dual-use research. The scientific community cannot afford to be bystanders in these efforts. This is not merely a matter of self-interest. Scientists have a social responsibility to inform the scientific community, the public, and policy-makers of the potential dangers of their work, as well as of the risks and lost opportunities associated with restricting the flow of scientific information. There may be good reasons for governments to control dissemination, but they should understand what the consequences may be for science and policy.